This study is designed to see whether stereotactic body radiation therapy (SBRT) can reduce tumour size, slow progression of the disease, prolong life and improve quality of life of patients with hepatocellular carcinoma, a cancer of the liver, that cannot be removed surgically (unresectable) and cannot be treated with ablative therapy (e.g. radio-frequency ablation) or trans-arterial chemo-embolization (TACE) therapy (delivery of chemotherapy through an artery that feeds into the liver). SBRT is concentrated focused radiation therapy delivered very precisely to the liver tumour. It is hoped that knowledge obtained from this study will improve our ability to treat patients with liver tumours that cannot be treated with surgery and other methods, and that SBRT may prove to be a treatment that can lead to long-term and permanent control of liver tumours for some patients.
From July 2003 to May 2007, over 40 patients with hepatocellular carcinoma participated in two studies at Princess Margaret Hospital (PMH) designed to determine the safety of treating hepatocellular carcinoma with SBRT. These studies have shown that SBRT can be delivered safely to the majority of patients with hepatocellular carcinoma. The treated tumour was controlled (shrank or remained the same size) in 78% of patients at one year following treatment.The median survival of patients was 11 months (i.e. half of patients survived longer and half shorter than 11 months). This survival rate is better than that expected in patients treated with supportive care only (no treatment other than care to make you feel better). Supportive care patients have a median survival rate of 3-9 months. We expect that the benefits of SBRT in this study will be similar to those observed in our initial studies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
92
Radiation therapy will be delivered on six occasions, over two weeks. Each treatment will take approximately 30 minutes to deliver.You may be asked to swallow 250 cc of oral contrast before each radiation therapy treatment.Pepto Bismol (a liquid that coats the stomach and is used to treat heartburn) and/or water may be combined with the contrast to improve the quality of the stomach's image.
University Health Network, Princess Margaret Hospital
Toronto, Ontario, Canada
Determine one year local progression free rate, defined as lack of progression within the irradiated volume, using RECIST criteria
Time frame: 5 years
Overall progression free survival
Time frame: 5 years
Overall survival
Time frame: 5 years
Quality of life
Time frame: 5 years
CTC3.0 toxicity
Time frame: 5 years
Cytokine response to radiation and association with complications
Time frame: 5 years
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